AdvaMed® Position Statement Regarding Transition to National Reimbursement Codes
This AdvaMed® position statement is intended to provide clarity about the transition away from the acronyms NDC/NHRIC to NRC, including rationale and implications.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed® Welcomes EPA Extension of Comment Period for Complex Medtech Sterilization Regulations, Says There’s “Not Nearly Enough” Time to Review Proposals Critical to Public Health
AdvaMed®, the Medtech Association, today welcomed the U.S. Environmental Protection Agency (EPA) extension of 15 more days for public comment on two proposed updates to regulations governing the use of…
FDA’s Dr. Califf Calls for Diagnostic Regulatory Reform, a Long-Time AdvaMed® Priority
WASHINGTON, D.C. – Following a Congressional hearing on “Preparing for and Responding to Future Public Health Security Threats,” AdvaMed®, the Medtech Association, released a statement from President and CEO Scott Whitaker echoing the…
Clinical Trial Site Budgeting –Risk Mitigation or Budget Control?
Join NAMSA for a webinar that will highlight clinical trial site budgeting as both a risk mitigation strategy and an approach for sponsors to standardize site costs.
Fact Sheet: EtO Sterilization Prevents Infection
Each year in the U.S., ethylene oxide sterilizes 20 billion medical devices, which are critical to preventing serious, even life-threatening, infections.
China: Key Regulatory Changes from 2022 and Look Ahead to 2023
Get the latest on NMPA’s updated guidance for the clinical evaluation of medical devices.
Navigating Trends and Best Practices For Cardiovascular Device Development
Join NAMSA and the FDA as they present a webinar on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA.
15th Annual FDA/AdvaMed® Medical Device Statistical Issues Conference
Join leading authorities from FDA, academia and industry to address the latest statistical trends and issues facing medtech organizations.
AdvaMed® Outlines Four Key Priorities in Letter to President on Sterilization
In a letter to the White House, the Advanced Medical Technology Association® (AdvaMed®) outlined four key priorities in pending regulations for facilities sterilizing medical devices with ethylene oxide (EtO).
Regulations and Reimbursement of Software as a Medical Device in Europe- Part1
This publication series explores “Software as a Medical Device (SaMD),” its challenges and the ways regulatory bodies try to address them, as well as the expected development of regulations related…